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Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717054
First Posted: July 16, 2008
Last Update Posted: May 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Drexel University
Results First Submitted: March 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Nausea
Vomiting
Interventions: Drug: Aprepitant
Drug: Scopolamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aprepitant and Scopolamine Group

Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.

Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Aprepitant and Placebo Scopolamine Group

Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.

Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery


Participant Flow:   Overall Study
    Aprepitant and Scopolamine Group   Aprepitant and Placebo Scopolamine Group
STARTED   58   57 
COMPLETED   58   57 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Aprepitant and Scopolamine Group

Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.

Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Aprepitant and Placebo Scopolamine Group

Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.

Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Total Total of all reporting groups

Baseline Measures
   Aprepitant and Scopolamine Group   Aprepitant and Placebo Scopolamine Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   57   115 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.3  (11.06)   47.2  (11.27)   46.8  (11.17) 
Gender 
[Units: Participants]
     
Female   51   52   103 
Male   7   5   12 


  Outcome Measures
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1.  Primary:   Number of Participants With Nausea and Vomiting   [ Time Frame: 24 hours postoperatively ]

2.  Secondary:   Number of Participants With Nausea and Vomiting in PACU   [ Time Frame: Postoperatively, up to 2 hours ]

3.  Secondary:   Total Vomiting   [ Time Frame: 24 hours postoperatively ]

4.  Secondary:   Need for Antiemetic Medication   [ Time Frame: 24 hours postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Green, DO
Organization: Drexel University College of Medicine
phone: 215-762-7798
e-mail: michael.green@drexelmed.edu



Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT00717054     History of Changes
Other Study ID Numbers: 00659737
First Submitted: July 15, 2008
First Posted: July 16, 2008
Results First Submitted: March 5, 2014
Results First Posted: April 29, 2014
Last Update Posted: May 20, 2014